用反相高效液相色谱法同时测定复方酮康唑软膏中三组分的含量
投稿时间:2020-06-20  修订日期:2021-03-13  点此下载全文
引用本文:吴博,王铁柱,拜年,刘冰,宋洪涛.用反相高效液相色谱法同时测定复方酮康唑软膏中三组分的含量[J].药学实践杂志,2021,39(2):152~156
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吴博 新疆医科大学第一附属医院药剂科新疆 乌鲁木齐 830000  
王铁柱 新疆医科大学第四附属医院重症医学科新疆 乌鲁木齐 830000  
拜年 新疆医科大学第一附属医院药剂科新疆 乌鲁木齐 830000  
刘冰 新疆医科大学第一附属医院药剂科新疆 乌鲁木齐 830000  
宋洪涛 中国人民解放军联勤保障部队第九〇〇医院药学科福建 福州 350025 sohoto@vip.163.com 
中文摘要:目的 建立同时测定复方酮康唑软膏中酮康唑、莫匹罗星和糠酸莫米松含量的方法。方法 采用反相高效液相色谱法,色谱柱为Intersil ODS-3(250 mm×4.6 mm,5 μm),流动相为甲醇-pH5.5磷酸盐缓冲液(65∶35),柱温45 ℃,流速1.0 ml/min,检测波长248 nm。结果 方法学验证表明,酮康唑、莫匹罗星和糠酸莫米松3种成分线性关系良好(r0.9995),日内日间精密度均小于3.0%,回收率在90%~108%之间,稳定性和重复性的RSD均小于3.0%,符合方法学要求。按照新建立的方法测定了3个批次样品中三组分的含量,结果符合要求。结论 该方法简便可靠,可为复方酮康唑软膏的质量控制提供依据,也为其质量标准研究奠定了基础。
中文关键词:反相高效液相色谱法  酮康唑  莫匹罗星  糠酸莫米松
 
Determination of three constituents in compound ketoconazole ointment by RP-HPLC
Abstract:Objective To establish a RP-HPLC method for determination of ketoconazole, mupirocin and mometasone furoate in compound ketoconazole ointment.Methods RP-HPLC was conducted on a Intersil ODS-3 column (250 mm×4.6 mm, 5 μm), with methanol-PBS with pH 5.5 (65:35) as the mobile phase and the column temperature was 45 ℃. The flow rate was 1.0 ml/min, and the detection wavelength was 248 nm.Results The methodological verification showed that ketoconazole, mupirocin and mometasone furoate had a good linearity (r0.9995). The inter/intra-day precisions were less than 3.0%, The recovery rates were between 90% and 108%. The stability and repeatability of RSD were also less than 3.0%, which met the requirements of method validation. The contents of the three components in three batches were determined by the new method.Conclusion The method is simple and reliable. It can provide a basis for the quality control of compound ketoconazole ointment and lay a foundation for its quality standard research.
keywords:RP-HPLC  ketoconazole  mupirocin  mometasone furoate
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